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CTRI Number  CTRI/2024/07/070228 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 01/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the inhalational anaesthetics and intravenous agents in incidence of emergence agitation,restlessness in surgeries performed in children with less duration  
Scientific Title of Study   Comparison of the effects of inhalational anaesthetics and total intravenous anaesthesia on the incidence of emergence delirium in paediatric surgeries less than 3 hours duration  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeno Shelton V  
Designation  PG Registrar  
Affiliation  Christian Medical College Vellore  
Address  Department of anesthesiology Christian medical college Vellore Tamilnadu 632004 INDIA

Vellore
TAMIL NADU
632004
India 
Phone  9095313153  
Fax    
Email  jenoshelton@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ekta Rai  
Designation  Professor  
Affiliation  Christian medical college Vellore  
Address  Department of anesthesiology Christian Medical College Vellore Tamilnadu India

Vellore
TAMIL NADU
632004
India 
Phone  9789250113  
Fax    
Email  drektarai@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Ekta Rai  
Designation  Professor  
Affiliation  Christian medical College Vellore  
Address  Department of anesthesiology Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9789250113  
Fax    
Email  drektarai@yahoo.com  
 
Source of Monetary or Material Support  
Fluid Research Grant Christian Medical College Vellore 632004 Tamilnadu  
 
Primary Sponsor  
Name  Jeno Shelton V  
Address  Department of anesthesiology Christian Medical College Vellore 632004 Tamilnadu  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jeno shelton V   Christian Medical College  Operating room Department of anaesthesiology Christian Medical College Vellore Tamilnadu
Vellore
TAMIL NADU 
9095313153

jenoshelton@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board and Ethics Committee of CMC Vellore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified, (2) ICD-10 Condition: N499||Inflammatory disorder of unspecified male genital organ, (3) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inhalational anaesthetics Isoflurane  Dose- 1 to 2 percentage with target minimum alveolar concentration MAC of 0.9 Frequency- continuous Route of administration- inhalataion Total duration- upto 3 hours till the end of procedure 
Intervention  Intravenous anaesthesia with Propofol in maintenance of anaesthesia   Dose -100 TO 250 microgram per kilogram per hour with target bispectral index 40 to 60 Frequency - continuous infusion Route of administration - intravenous route Total duration- upto 3 hours till the end of procedure 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patients undergoing elective Genitourinary, Gastrointestinal, Limb surgeries with less than 3 hours duration. ASA physical status I, II  
 
ExclusionCriteria 
Details  Patient refusal
ASA physical status III or more
Age less than 2 years and more than 12 years
History of allergic to anaesthetic drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of Emergence Delirium between inhalational and intravenous anaesthestics given as maintenance of anaesthesia using PAED scale  2 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of Nausea and Vomiting among two grups
To compare post operative Analgesia among two groups
To estimate the duration of PACU stay among two groups  
2 hours 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The use of inhalational agents as maintenance is widely practiced in the world. Meanwhile the use of TIVA is also the best choice in paediatric anaesthesia. So it is always a debate for inhalational or tiva in management. Emergence agitation is the important issue in paediatric anaesthesia especially with inhalational agents. It may precipitate maladaptive behaviour, memory impairment also.Considering the pharmacological action of propofol, TIVA can be a good alternative in this. The ideal anaesthetic should be the one with rapid emergence and short stay in PACU without any side effects. The factors contributing to emergence delirium are multifactorial including age,perioperative anxiety,pain,personal character of patient,type of surgery,rapid awakening, and the anaesthetic agent used4 . Emergence delirium leads to increased chances of wound dehiscence ,damage to surgical repair,bleeding,pulling out of drain,iv access , physical self harm to child, delayed recovery and prolonged hospital stay. This behaviour is often difficult to manage by the caregivers and needs constant supervision and leads to parental dissatisfaction 5. Once emergence delirium has occurred ,it increases the recovery time in PACU,predisposes their parents or caregivers to anxiety and stress Chandler et al7 showed a lower incidence of ED after total intravenous anesthesia (TIVA) than that after SEVO anesthesia in children aged 2–6 years following strabismus surgery. Most studies shows the children with TIVA has shown reduced incidence of emergence agitation when compared to inhalational agents. In inhalational agent, sevoflurane has higher incidence than isoflurane. But the role of sevoflurane is needed as it is the induction agent of choice for pediatrics in whom securing iv line is not possible for intravenous induction as well as slow and irritant odour inhalataional agent isoflurane is also not practically used when the child is awake. In our routine practice in the institution, sevoflurane for induction and isoflurane for maintenance of anaesthesia is used.So the use of total intravenous anaesthesia in maintenance is not clearly studied yet in pediatric surgeries. Our study aims to compare the quality of recovery in terms of incidence of emergence delirium with the usage of inhalational agent-isoflurane and total intravenous anaesthesia with propofol in children undergoing surgical procedures with duration less than 3 hours.

All the children with ASA 1-2 with age group of 2 to 12 years who are undergoing surgeries – GI,genitourinary,limb surgeries with duration less than 3 hours will be recruited. Informed consent who fulfill the inclusion criteria will be obtained for participation in the study before the procedure. In the operating room standard ASA(American society of anaesthesiologists) monitors will be established – Spo2,ECG,NIBP,ETCO2,and bispectral index (BIS)monitor. Sealed envelopes are used for allocation with two groups. Group A will have isoflurane as maintenance and group B will have propofol for maintenance of anaesthesia. This is randomized controlled trial. The investigator will be blinded to the allocation. Both groups will have endotracheal intubation after administration with atracurium(0.5 mg/kg) and ventilated with tidal volume of 6-8 ml/kg. The endtidal carbondioxide is maintained between 30 and 35 by adjusting respiratory rate and tidal volume. 

 Group A (isoflurane group) In inhalational group, Mask induction was performed with mixture of  N2O and O2 for 60 s followed by incremental increases in inspired sevoflurane. Following loss of consciousness, an intravenous line was established, fentanyl 0.5 mg/kg is given and then maintained with inhalational agent- isoflurane with its MAC will be maintained less than 0.9 . 

 Group B (TIVA group) In TIVA group Mask induction was performed with mixture of N2O and O2 for 60 s followed by incremental increases in inspired sevoflurane . Following loss of consciousness, an intravenous line was established, fentanyl 0.5mg/kg is given and then maintained with propofol infusion 100 – 250 mcg/kg/hr administered to achieve appropriate depth of anaesthesia indicated by BIS score of 40 to 60. 

 Once all the procedures were completed, the patients were extubated and transferred to the postanesthesia care unit (PACU). The data regarding post operative outcomes will be recorded by the recovery nurse who will be blinded to the anaesthetic methods. Quality of recovery,postoperative pain, postoperative nausea vomiting, and extubation time will be taken into record. The extubation time will be calculated as the time from the end of anesthesia to extubation of the nasotracheal tube. In the PACU,the time taken till the child shows appropriate response is noted. Also the patients will be evaluated at10 min intervals using the Aldrete scale. The Aldrete scoring system is used to clinically evaluate the physical status of patients recovering from general anesthesia. A score of 0–2 is given for each of the five categories (activity, circulation, consciousness, O2 saturation, and respiration) with a maximum score of 10. Recovery time will be calculated from the patient’s arrival to the PACU to the achievement of an Aldrete score of more than or equal to 9. The Pediatric Anesthesia Emergence Delirium (PAED) scale will be used to assess patients on the following five psychometric items: 1. the child makes eye contact with the caregiver; 2. the child’s actions are purposeful; 3. the child is aware of his or her surroundings; 4. the child is restless; and 5. the child is inconsolable. Items 1–3 are reversed scored as follows: 4-not at all; 3-just a little,2-quite a bit,1-very much,and 0-extremely. Items 4 and 5 are scored as follows- 0-not at all, 1-just a little,2-quite a bit,3-very much,and 4-extremely. The scores of each item are summed to obtain a total PAED score.2 ED increases directly with the total score. A PAED score of more than10 will signify the presence of emergence delirium. The Face, Legs, Activity, Cry, Consolability (FLACC) scale will be used to assess the postoperative pain. Responses in each category will be scored between 0 and 2, for a maximum total score of 10. A pain score is obtained by reviewing the descriptions of behavior in each of the FLACC categories and selecting the number that most closely matches the observed behavior. The numbers obtained for each category are added to obtain the total pain score, which will be between 0 and 10.10 Observational scoring was performed immediately after the patient was sufficiently alert to make purposeful movements. The same blinded nurse will monitor the children for 40 min in the PACU. The PAED and FLACC scores will be evaluated every 10 min during the observation period, and the highest scores will be recorded for analysis.

 

 
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